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DBV Soars As Path For Peanut Allergy Patch Approval Clears

Positive FDA Feedback After Earlier Rejection

 
• By Kevin Grogan

The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.

Peanut_Butter
DBV hopes to help children with peanut allergy • Source: Archive

DBV Technologies' peanut allergy patch has been on shaky ground since a rejection from US regulators in August last year but the path to potential approval has become clearer after the French firm's positive meeting with the Food and Drug Administration.

The future for DBV looked bleak last summer when the FDA issued a complete response letter to the biologics license application for Viaskin Peanut, the firm's once-daily epicutaneous immunotherapy (EPIT)...

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